Meteospasmyl capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

alverine (alverine citrate), simeticone

Available from:

Laboratoires MAYOLY SPINDLER

ATC code:

A03AX58 օրիգինալ դեղի առաջին դեղաձև, դեղաչափ և թողարկման ձև

INN (International Name):

alverine (alverine citrate), simeticone

Dosage:

60mg+ 300mg (20/2x10/) in blister, (30/3x10/) in blister

Pharmaceutical form:

capsules

Units in package:

60mg+300mg (20/2x10/) in blister, (30/3x10/) in blister

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2020-11-07

Summary of Product characteristics

MS-EN-APH-0001 – SPC – METEOSPASMYL, soft capsule of 23/01/2020
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SUMMARY OF PRODUCT CHARACTERISTICS
1)
NAME OF THE MEDICINAL PRODUCT
METEOSPASMYL, soft capsule
2)
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1 GENERAL DESCRIPTION
Soft oblong capsule, size 6, shiny opaque white, containing a thick
whitish suspension.
2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Alverine citrate
..................................................................
60.00 mg
Simeticone
........................................................................
300.00 mg
For 1 soft capsule.
For the full list of excipients, see section 6.1.
3)
PHARMACEUTICAL FORM
Soft capsule.
4)
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of functional bowel disorders, especially those
with bloating.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
FOR ADULTS ONLY.
One soft capsule 2 to 3 times a day at the beginning of meals or when
in pain.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
LIVER FUNCTION:
Elevations in ALT (Alanine Aminotransferase) and AST (Aspartate
Aminotransferase) > twice the upper
limit of normal (ULN) have been reported in patients receiving
treatment with alverine/simeticone. These
MS-EN-APH-0001 – SPC – METEOSPASMYL, soft capsule of 23/01/2020
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elevations may be associated with a concomitant elevation in total
serum bilirubin (see section 4.8). In case
of an elevation in hepatic aminotransferases > 3 times the ULN and
even more so in the case of jaundice,
treatment with alverine/simeticone should be discontinued.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
The available to date data do not suggest the existence of clinically
significant interactions.
4.6
PREGNANCY AND LACTATION
PREGNANCY
_Simeticone_: No effect is expected during pregnancy with the intake
of simeticone due to negligible systemic
exposure.
_Alverine_: There